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Completed

NCT Number: NCT00141232

Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes

The AFORRD trial is asking three important questions:

What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?

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Key information

Conditions

Diabetes, Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Irvine, Ayrshire, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry.
  • Are not known to have had a cardiovascular event

Exclusion criteria

  • They are taking prescribed lipid lowering therapy
  • Have triglycerides > or = 8.0 mmol/L

Treatment and study plan

Atorvastatin and Omega-3 fatty acids

Drug

Primary outcomes

  1. Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured

  2. LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:

  3. Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)

Secondary outcomes

  1. Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16.

  2. Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Collaborators

  • Churchill Hospital

Registry information

Official study title

A Multicentre, Randomised, Double Blind Placebo Controlled Trial Evaluating Atorvastatin in Factorial With Omega-3 Fatty Acids Cardiovascular Risk Reduction in Patients With Type 2 Diabetes

Acronym: AFORRD

Important dates

Study start
2004
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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